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Oral Lactobacillus Crispatus Lc-G22 as Adjunctive Therapy for Vulvovaginal Candidiasis
Sponsor: BioGrowing Co., Ltd
Summary
This single-center, randomized, single-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of oral Lactobacillus crispatus Lc-G22 as adjunctive therapy to clotrimazole for preventing recurrence of vulvovaginal candidiasis (VVC). One hundred women aged 18-50 years with a history of ≥2 VVC episodes and current positive fungal microscopy were randomized 1:1 to receive clotrimazole vaginal tablets plus oral Lc-G22 (5×10⁹ CFU, twice daily for 60 days) or clotrimazole plus matching placebo. The primary outcome was overall clinical response rate at Month 3. Secondary outcomes included mycological negativity rate, VVC clinical scores, vaginal microecological parameters, and cumulative recurrence rate over 12 months. Safety was assessed by adverse event incidence.
Official title: Efficacy and Safety of Oral Lactobacillus Crispatus Lc-G22 as Adjunctive Therapy to Clotrimazole for Preventing Recurrence of Vulvovaginal Candidiasis: A Single-Center, Randomized, Single-Blind, Placebo-Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-07-01
Completion Date
2024-10-31
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
Lactobacillus crispatus Lc-G22
Oral capsules containing 5×10⁹ CFU live Lactobacillus crispatus Lc-G22 (lyophilized powder), provided by BIOGROWING CO., LTD. One capsule twice daily with meals for 60 consecutive days.
Placebo
Oral capsules containing maltodextrin, identical in appearance to Lc-G22 capsules. Same dosing schedule: one capsule twice daily for 60 days.
Locations (1)
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China